FDA UDI Not in Commercial Distribution 🇺🇸 United States

STERLING

DI: 00366975012814 · Model: 4983-566 · BENCO DENTAL SUPPLY CO.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
STERLING
Primary DI
00366975012814
Version / Model
4983-566
Company Name
BENCO DENTAL SUPPLY CO.
Labeler DUNS
015108087
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-06-13
Public Version
1
Public Version Date
2023-06-21
Public Version Status
New
Public Device Record Key
e0f61f51-915a-454b-8f89-14072baa294e
Distribution End Date
2023-06-13

Device Description

STERLING® Supreme 3W Diode Laser

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
Yes
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
GEX Powered Laser Surgical Instrument

GMDN Terms

Code Name
60340 Dental diode laser system

Identifiers

Type ID
Primary 00366975012814